This invention relates in general to mental health, and in particular to a system and method useful in the treatment of mood disorders.
A bibliography for the following text appears at the end of the specification and before the claims hereof. Mood disorders are mental illnesses in which a person experiences emotions outside the normal boundaries of sadness and elation. The most commonly occurring mood disorder is a major depressive disorder, which features one or more episodes of depression (APA 1994). Bipolar disorder features one or more episodes of mania or episodes of both mania and depression (APA 1994). Other mood disorders are dysthymia (persistent low-grade depression) and cyclothymia (mild moodswings).
Mood disorders occur commonly. In the USA, the National Comorbidity Study showed a lifetime prevalence of 17% for major depressive disorder and 1.6% for bipolar disorder (Kessler 1994).
Mood disorders are associated with high morbidity and mortality. Despite current treatments, episodes recur frequently. Following an initial episode, the probability of recurrence in major depressive disorder is 50-85% (Mueller 1999). In bipolar disorder, the probability of recurrence by 5 years is 90% (Tohen 1990). Dysthymia is associated with a marked increase in risk of developing major depressive episodes. (Keller Shapiro 1982).
Many patients do not obtain full recovery between episodes. In 20-30% of those with major depressive disorder, the depressive symptoms persist for longer than a year after treatment of the acute phase and 12% do not recover by 5 years (Keller 1992). In bipolar disorder, episodes of mania and depression are often protracted with 24% of patients remaining acutely ill after 1 year, 16% after 2 years and 9% after 5 years (Keller 1993). Many patients with depressive disorder or bipolar disorder report residual symptoms that impose considerable morbidity despite successful treatment (Fava 1999). As a consequence, many patients with bipolar disorder (Gitlin 1995) and major depressive disorder (Thase 1995) will develop a chronic and disabling course. Both major depressive disorder and bipolar disorder are among the top ten causes of worldwide disability (Murray 1996).
Mood disorders have a large economic impact on society. The costs of depression are estimated to be similar to those of cancer and ischemic heart disease, due to reduced productivity and increased use of healthcare resources (Greenberg 1993). A 1991 report from the National Institutes of Mental Health estimated the annual costs of bipolar disorder to be $45 billion (Wyatt 1991).
The disability and suffering in mood disorders impacts all aspects of life. Psychosocial impairment has been found to persist for years after an episode of mania or depression even for patients in remission (Coryell 1993). Mood disturbances are associated with high workplace absenteeism (Broadhead 1990) and poor well-being compared to those with chronic medical illnesses (Wells 1990).
Suicide is the most severe complication of mood disorders. Patients with major depressive disorder or bipolar disorder are more likely to attempt or complete suicide than any other medical group (Goodwin and Jamison 1990). A review of 31 studies of patients with major depressive disorder or bipolar disorder found a lifetime prevalence of suicide ranging from 9 to 60% (Goodwin and Jamison 1990).
The treatment of mood disorders is complex and usually requires a patient to take multiple medications several times a day. Maintenance therapy to prevent a recurrence of major depressive disorder may last several years or more. Maintenance therapy for bipolar disorder is usually for the patient""s lifetime.
Most medications used to treat psychiatric disorders have uncomfortable side effects such as weight gain, tremors, hair loss and cognitive dulling. Although the combinations of drugs needed to treat mood disorders improve response, they also increase side effects and patient costs. Polypharmacy schedules can be difficult to adhere to. Thus, an understanding of the disorder and long-term commitment to the treatment is needed from the patient. Patient non-compliance with medication is a serious problem and the major factor that accounts for patient relapse. Studies show rates of non-compliance with maintenance therapy in between 24-53% of patients with major depressive or bipolar disorders (Schumann 1999, Simon 1993, Aagaard 1988, Berghofer 1996).
Daily patient self-reporting of mood and sleep is well established as a valuable clinical tool (Bauer 1991; Leverich and Post 1996). Mood disorders are characterized by rapid changes in mood making treatment decisions difficult. The prospective semi-continuous measure of infradian (daily or longer) fluctuations of patients"" mood and sleep allows for detailed assessment of frequency and pattern of illness (Denicoff 1997). Simultaneous comparison of daily mood fluctuations and medications may help to optimize and rationalize complex pharmacological therapy and to better detect nuances of partial response (Post 1997). Another benefit of daily self-reporting of mood is increased patient involvement in their care.
Two methodologies are currently used for daily patient self-reporting of mood: the Life Chart Methodology (Leverich and Post 1996) and the Chronosheet developed by Whybrow in the 1970s. The latter uses a 100-mm visual analogue scale (VAS) between the mood extremes of mania and depression on which the patient marks mood proportionately (Bauer M S 1991). The Chronosheet also records sleep, weight, psychiatric medications and life events. Both self-rating methodologies are paper and pencil based. The patient is given a form or booklet to complete by hand daily. The patient returns the completed form to staff monthly for data entry into a computer for analysis. There are several problems with a paper-based process. Data entry is very time-consuming and expensive. Overall data quality is negatively impacted by data entry errors. It is then necessary to manually digitize the VAS data for computer entry. Any data transformations performed by humans provide additional opportunities for error.
Accordingly, there is a need for a method and system to automate patient charting that is simple for patients to use and will provide physicians with an immediate display and data analysis of the results. More specifically, there is a need for an automated system that will record longitudinal data useful in the treatment of mood disorders, such as mood, sleep, medications, life events, weight changes and menstrual data. Moreover, there is a need for a system that will automatically provide a time-based visual display of the relationships between changes in mood, sleep, medications, life events, weight and menstrual data.
The present invention is a system and method for providing immediate longitudinal analysis of patient data to assist clinicians with treatment of mood disorders. Patients are enrolled in an administrative system on a computer at the physician""s office. Patients are trained to install software on a home computer and then taught how to enter data accurately. A graphical user interface makes the software easy and fast for daily patient use. Patients enter their mood, sleep, medications taken, life events; and, if female menstrual data, every day and weight weekly. Patients without a home computer can use a computer at a mental health facility. Patients return data to the administrative system via E-Mail over the Internet or via diskette. Clinicians can obtain both descriptive charts and statistical analyses of all collected patient data in the administrative system.
This invention overcomes current deficiencies and allows a patient to enter daily mood and other clinical data directly into a home computer or into a computer at a mental health facility.
An advantage of the present invention is that clinicians can immediately obtain both descriptive charts and statistical analyses of the collected patient data to assist with clinical decision-making.
Another advantage of the present invention is that an automated charting system may be perceived by the patient more positively wherein one may be more apt to cooperate rather than with using a paper and pencil system, thereby improving compliance.
Another feature of the present invention is that data may be collected, displayed and analyzed in perpetuity for individual patients. Any time period in a patient""s data can be selected for immediate display and analysis.
Another feature of the present invention is that data from multiple patients may be easily aggregated for use in clinical research.
These and other objects, which will become apparent as the invention is described in detail below, are provided in a computer system having a storage device, a method for gathering clinical data useful in the clinical analysis and treatment of mood disorders. The method includes such steps as displaying a main menu including a multiplicity of icons depicting inquiries to be answered by a patient; and, storing the patient""s answers to the inquiries as clinical data generated on a regular basis by the patient. The method further includes selecting a point on a scale depicting the patient""s current mood; selecting a sleep icon for updating sleep data; and, selecting a medication icon for updating type and amount of medication taken. The present invention is also capable of creating longitudinal charts and statistics based on selections made by a patient over a given period of time.
Still other objects, features and advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description, wherein is shown and described only the preferred embodiment of the invention, simply by way of illustration of the best mode contemplated of carrying out the invention. As will be realized, the invention is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive, and what is intended to be protected by Letters Patent is set forth in the appended claims. The present invention will become apparent when taken in conjunction with the following description and attached drawings, wherein like characters indicate like parts, and which drawings form a part of this application.